IBUPROFEN  - ibuprofen tablet, coated 
IBUPROFEN - ibuprofen tablet, coated 
Polygen Pharmaceuticals LLC

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Ibuprofen Tablets,  200 mg

Active ingredient(s)


Ibuprofen 200 mg (NSAID)*

 * nonsteroidal anti-inflammatory drug


Purpose


Pain reliever/Fever reducer


Use(s)

temporarily relieves minor aches and pain due to:

Warnings

Allergy alert: Ibuprofen may cause a severe allergy reaction, especially in people allergic to aspirin.

Symptoms may include: 


If an allergic reaction occurs, stop use and seek medical help right away.


Stomach bleeding warning:
This product contains an NSAID, which may cause stomach bleeding. The chance is higher if you:

Do not use


Ask a doctor before use if

Ask a doctor or pharmacist before use if

When using this product

Stop use and ask doctor if

Side effects occur. You may report side effects to PolyGen at 1-888-291-7337 and/ or FDA at 1-800-FDA-1088

Pregnancy/Breastfeeding


ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children


In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)


Directions


adults and children
12 years and older:
· take 1 tablet every 4 to 6 hours while symptoms persist
· if pain or fever does not respond to 1 tablet, 2 tablets may be used
· do not exceed 6 tablets in 24 hours unless directed by a doctor
children under 12 years:
ask a doctor

other information



Inactive ingredient


colloidal silicon dioxide, croscarmellose sodium, iron oxide red, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, pregelatinized starch, talc, titanium dioxide

Storage

Questions


1-888-291-7337


Principal Display Panel


CARTON LABEL PDP

 

NDC: 52605-114-01

 

Compare to the active ingredient in Advil®

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

100 COATED TABLETS

 

SEE NEW WARNINGS INFORMATION
 


Ibuprofen


BOTTLE LABEL PDP

NDC: 52605-114-01

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

100 COATED TABLETS

 

SEE NEW WARNINGS INFORMATION



ibu200tabbottlab


CARTON LABEL PDP

 

NDC: 52605-117-01

 

Compare to the active ingredient in Advil®

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER (NSAID)

 

100 COATED CAPLETS

 

SEE NEW WARNINGS INFORMATION



ibucarton100






BOTTLE LABEL PDP

NDC: 52605-117-01

 

IBUPROFEN TABLETS, USP 200 mg

PAIN RELIEVER/ FEVER REDUCER(NSAID)

 

100 COATED CAPLETS

 

SEE NEW WARNINGS INFORMATION



ibubott100




IBUPROFEN  
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52605-114
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
POLYVINYL ALCOHOL 
Product Characteristics
ColorBROWNScoreno score
ShapeROUNDSize10mm
FlavorImprint Code 114
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52605-114-011 in 1 CARTON
1100 in 1 BOTTLE
2NDC:52605-114-101000 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123906/05/2012
IBUPROFEN 
ibuprofen tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:52605-117
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IBUPROFEN (IBUPROFEN) IBUPROFEN200 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
COLLOIDAL SILICON DIOXIDE 
FERRIC OXIDE RED 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
TALC 
TITANIUM DIOXIDE 
STARCH, CORN 
POLYVINYL ALCOHOL 
Product Characteristics
ColorBROWNScoreno score
ShapeCAPSULESize15mm
FlavorImprint Code 117
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52605-117-011 in 1 CARTON
1100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA09123906/05/2012
Labeler - Polygen Pharmaceuticals LLC (962415720)
Registrant - Polygen Pharmaceuticals LLC (962415720)
Establishment
NameAddressID/FEIBusiness Operations
Marksans Pharma Limited925822975MANUFACTURE(52605-117)

Revised: 6/2013
Document Id: c265106e-3575-4073-8195-0aa0adb10f45
Set id: 00bc1e01-f90e-444d-b7d6-807797a1d136
Version: 6
Effective Time: 20130627
 
Polygen Pharmaceuticals LLC